Mechanisms for moving, guiding and/or steering invasive medical instruments, such as catheters, in living tissue for therapeutic, diagnostic and surgical purposes are well known in the art. Technologies have been developed that enable locating and tracking medical devices inserted within the body, including determining the orientation of a point on the device, such as the tip of a catheter. Locating a surgical object within living tissue can be accomplished in a variety of ways, including using various forms of electromagnetic or ultrasound energy. Numerous catheter steering and deflection mechanisms are known in the art.
U.S. Pat. No. 6,083,170 to Ben-Haim, which is assigned to the assignee of the present application and is incorporated herein by reference, describes a flexible, elongate probe having a distal end for insertion through physiological tissue, typically through a lumen in the tissue. The probe includes a sensor, which generates signals indicative of a characteristic of the tissue in a vicinity of the probe, and an alignment mechanism, which deflects the distal end of the probe in response to the signals. The signals may be indicative of obstructions or of the direction of a clear channel in the lumen.
U.S. Pat. No. 5,492,131 to Galel, which is incorporated herein by reference, describes a catheter guided by directional control inside a bodily passage by a servo-type system which includes a sensor to transmit position, orientation or velocity information to a microprocessor which is typically programmed with an error detection algorithm, and a motion control system. The motion control system generates a signal representative of the change in position, orientation or velocity needed to guide the catheter along a prescribed course of travel or in general to continuously adjust its position relative to a target. This signal is transmitted to a directional steering system, a forward drive system, or both, to effect the change. The result is described as a closed-loop servo system capable of automated, preprogrammed advancement and/or positioning of the distal catheter tip through branched and convoluted passages to a site where therapeutic action is needed or from which diagnostic information is sought.
U.S. Pat. No. 5,779,623 to Bonnell, which is incorporated herein by reference, describes a remote-controlled device for selectively positioning a medical instrument within a predetermined region of space. The device includes a clamp having two pivotally mounted sections enabling the clamp to be placed in either an opened position or a closed position. Each section has a drive wheel including an arc-shaped groove which accommodates the medical instrument when the clamp is placed in the closed position. Each of the wheels has a coupling gear positioned and configured to pivot apart when the clamp is placed in the open position with portions of teeth of the gears remaining engaged with each other. One of the drive wheels is directly driven by a motor housed in one of the sections of the clamp.
U.S. Pat. No. 6,436,107 to Wang et al., which is incorporated herein by reference, describes a surgical system that includes a remotely-controlled surgical instrument coupled to a tool driver that can spin and actuate the instrument. The instrument includes an actuator rod that is coupled to an end-effector and detachably connected to a push rod. The push rod can move relative to the handle to actuate the end-effector. The handle can be secured to the tool driver by inserting pins into corresponding slots that are located on both the instrument and the tool driver.
U.S. Pat. No. 5,754,741 to Wang et al., which is incorporated herein by reference, describes a robotic system that moves a surgical instrument in response to the actuation of a foot pedal that can be operated by the foot of a surgeon. The robotic system has an end-effector that is adapted to hold a surgical instrument such as an endoscope. The end-effector is coupled to a robotic arm assembly which can move the endoscope relative to the patient. The system includes a computer which controls the movement of the robotic arm in response to input signals received from the foot pedal.
U.S. Pat. Nos. 5,649,956 and 6,461,372 to Jensen et al., which are incorporated herein by reference, describe techniques for releasably holding a surgical instrument, such as an endoscopic instrument configured for delivery through a small percutaneous penetration in a patient. The instrument comprises an elongate shaft with a pair of mounting pins laterally extending from the shaft between its proximal and distal ends. An instrument holder comprises a support having a central bore and an axially extending slot for receiving the instrument shaft and the mounting pins. A pair of locking slots are cut into the support transversely to and in communication with the axial slot so that the mounting pins can be rotated within the locking slots. The instrument support further includes a latch assembly for automatically locking the mounting pins within the locking slots to releasably couple the instrument to the instrument holder. With this twist-lock motion, the surgeon is described as being able to rapidly engage and disengage various instruments from the holder during a surgical procedure, such as open surgery, laparoscopy or thoracoscopy.
PCT Publication WO 99/45994 to Beyar, which is incorporated herein by reference, describes a remote control catheterization system including a propelling device, which controllably inserts a flexible, elongate probe into the body of a patient. A control console, in communication with the propelling device, includes user controls which are operated by a user of the system remote from the patient to control insertion of the probe into the body by the propelling device.
US Patent Application Publication 2002/0143326 to Foley et al., which is incorporated herein by reference, describes techniques for assisting a surgeon in ablating conduction paths in tissue, such as heart tissue. A device can be configured to operate as a template that adheres to the tissue surface, and allows the surgeon to more easily sever the conduction path to form a lesion in a desired location. In particular, the template can be used to guide the surgeon's use of a surgical instrument along a desired ablation path. In some cases, the template may incorporate hardware that structurally supports the instrument for travel along the ablation path.
US Patent RE34,502 to Webster, Jr., which is incorporated herein by reference, describes a catheter comprising a symmetrical cylindrical control handle, an elongate tubular catheter body, and a flexible catheter tip having a lumen offset from the axis of the catheter tip. The control handle comprises a housing having a piston chamber at its distal end. A piston is mounted in the piston chamber and is afforded lengthwise movement. The proximal end of the catheter body is fixedly attached to the distal end of the piston. A puller wire is attached to the housing and extends through the piston, through and coaxial with the catheter body and into the offset lumen of the catheter tip where it is attached to the wall of the catheter tip. Lengthwise movement of the piston relative to the housing results in deflection of the catheter tip.
U.S. Pat. No. 6,210,407 to Webster, Jr., which is incorporated herein by reference, describes a bi-directional catheter comprising an elongated body, a tip section and a control handle. The body has at least one lumen extending therethrough. The tip section is mounted at the distal end of the catheter body and has at least two diametrically-opposed off-axis lumens, the first smaller than the second. The control handle comprises at least two members longitudinally movable between first and second positions. The catheter further comprises first and second puller wires. The proximal end of each puller wire is connected to an associated movable member of the control handle. Each puller wire extends from the control handle through a lumen of the catheter body. The first puller wire extends into the first lumen in the tip section, and the second puller wire extends into the second lumen in the tip section. The distal end of each puller wire is anchored to the tip section. Proximal movement of a movable member relative to the catheter body results in proximal movement of the puller wire associated with that movable member relative to the catheter body, and thus deflection of the tip section in the direction of the lumen in which that puller wire extends.
U.S. Pat. Nos. 6,066,125 and 6,123,699 to Webster, Jr., which are incorporated herein by reference, describe omni-directional steerable catheters, and U.S. Pat. Nos. 6,183,463 and 6,198,974 to Webster, Jr., which are incorporated herein by reference, describe bi-directional steerable catheters.
U.S. Pat. No. 3,470,876 to Barchilon, which is incorporated herein by reference, describes a steerable catheter with a distal end that is guidable through 360 degrees by means of four guide lines extending along the length of the catheter and differentially operated in pairs.
U.S. Pat. No. 4,920,980 to Jackowski, which is incorporated herein by reference, describes a catheter having a wire member loosely positioned in a bore thereof. The wire member is secured to the catheter at a position adjacent the distal end, such position being radially spaced from the axis of the catheter. The wire member extends through the bore and out of the proximal end of the catheter, so that the distal end of the catheter can be bent by pulling the wire member.
U.S. Pat. No. 5,489,270 to van Erp; U.S. Pat. Nos. 5,897,529, 5,938,603, 5,964,757, 6,171,277 and 6,210,362 to Ponzi; U.S. Pat. No. 6,402,719 to Ponzi et al.; and U.S. Pat. No. 6,165,139 to Damadian, all of which are incorporated herein by reference, describe steerable catheters.
U.S. Pat. No. 4,930,494 to Takehana et al., which is incorporated herein by reference, describes an endoscope that is bent using a shape memory alloy (SMA). The distal end of an insertion section of the endoscope is divided into a plurality of segments, each of which includes a pair of SMA coils which are arranged symmetrically with respect to an axis and memorize a close-winding shape. As the SMA coils recovers their memorized shape, the distal end of the insertion section is bent. The SMA coils are restored to the memorized shape when they are conductively heated by means of a current supply circuit. The current supply circuit comprises an input unit for inputting a target value of the bend angle for a leading segment, a sensor for detecting the distance of insertion of the insertion section, a detector circuit for detecting the bend angle of each segment, and means for controlling the amount of current supply so that the bend angle of the SMA coils agrees with a target angle. The inputted angle is set as the target angle for the leading segment, and the detected bend angle of each segment is set as the target angle for each succeeding segment. The set value is renewed each time the insertion distance of the insertion section attains a predetermined distance.
Kühl C et al., in “Virtual endoscopy: from simulation to optimization of an active endoscope,” ESAIM: Proceedings 12:84-93 (November 2002), which is incorporated herein by reference, describe a polyarticulated device actuated with SMA springs for endoscopy.
Haga Y et al., in “Small diameter active catheter using shape memory alloy coils,” Trans. IEE of Japan 120-E (No. 11):509-514 (2000), which is incorporated herein by reference, describe an active catheter having many joints comprising SMA coil actuators.
Otsuka K et al., in “Science and technology of shape-memory alloys: new developments,” MRS Bulletin 27:91-100 (February 2002), which is incorporated herein by reference, present an overview of recent progress in the field of SMAs, including a discussion of fundamental SMA concepts, and examples of applications.
Bar-Cohen Y, in “Transition of EAP material from novelty to practical applications—are we there yet?” Proceedings of EAPAD, Paper No. 4329-02 (March 2001), which is incorporated herein by reference, presents a review of current efforts and challenges in the field of electroactive polymers (EAPs), including the use of EAPs for catheter steering elements.
Bar-Cohen Y et al., in “Electroactive polymers (EAP) characterization methods,” Proceedings of SPIE's 7th Annual International Symposium on Smart Structures and Materials, Paper No. 3987-04 (March 2000), which is incorporated herein by reference, describe a new testing procedure for bending EAPs, in order to quantify their electrical and mechanical properties.
Razavinejad A, in “Ionic polymer metal composites,” ELE 482 BME Seminar (March 2002), which is incorporated herein by reference, presents an overview of ionic electroactive polymers (ionic EAPs, also known as ionic polymer metal composites (IPMCs)), which bend in response to an electrical activation as a result of the mobility of cations in the polymer network.
PCT Publication WO 98/43530 to Zilberstein et al., which is assigned to the assignee of the present invention and is incorporated herein by reference, describes an elongate probe having a longitudinal axis and a distal tip, and including at least one deflection mechanism, which includes an elastic flexible member, having distal and proximal ends and having a predetermined bending stiffness. The flexible member is fixed within the probe generally parallel to the longitudinal axis thereof. The probe further includes a pull wire having a distal end coupled to the distal end of the flexible member, and a proximal end that is tensioned longitudinally to deflect the probe.
U.S. Pat. No. 6,246,898 to Vesely et al., which is incorporated herein by reference, describes a method for carrying out a medical procedure using a 3-D tracking and imaging system. A surgical instrument, such as a catheter, probe, sensor, pacemaker lead, needle, or the like is inserted into a living being, and the position of the surgical instrument is tracked as it moves through a medium in a bodily structure. The location of the surgical instrument relative to its immediate surroundings is displayed to improve a physician's ability to precisely position the surgical instrument. The method is described as being able to be integrated with robotic surgery.
U.S. Pat. No. 6,470,205 to Bosselmann et al., which is incorporated herein by reference, describes a medical instrument for insertion into an examination subject, having an elongated instrument body formed by a number of successively arranged rigid sections, with respective, successive sections being connected to one another via articulated joints which can be angled relative to one another. The instrument is either fashioned in the nature of a robot arm, or as an instrument to be manually guided.
PCT Publication WO 02/074178 to Brock et al., which is incorporated herein by reference, describes a remotely controllable flexible instrument system for performing a medical procedure on a subject. The instrument system comprises: an instrument shaft having proximal and distal ends, the shaft being insertable into a subject so as to dispose the distal end of the instrument shaft internally within a subject; a shaft mount coupled to the instrument shaft at the proximal end of the instrument shaft; and a drive unit drivably coupled to the shaft mount. The instrument shaft comprises an elongated shaft that supports a medical procedure mechanism for performing the medical procedure at an internal target site. The elongated shaft is constructed and arranged such that some length of the shaft is inherently and sufficiently deformable so as to readily flex and pass atraumatically through an anatomic passage of the subject. The instrument further includes a remote user interface having a user input device connected to an electrical controller which receives commands from the user input device and transmits signals to the drive unit in accordance with manipulations of the user input device by a user. The electrical controller includes a command processing mechanism for controlling bending of one or more deformable lengths of the elongated shaft and movement of the medical procedure mechanism in accordance with manipulations of the user input device by the user.
U.S. Pat. No. 5,808,665 to Green, which is incorporated herein by reference, describes a teleoperator system with telepresence. The system includes right and left hand controllers for control of right and left manipulators through use of a servomechanism that includes a computer. The teleoperator system comprises an endoscopic surgical instrument suited for endoscopic surgery. The surgical instrument comprises a control servomechanism which operates an insertion section. The insertion section comprises a forearm, a wrist and an end-effector. The end-effector is a modified surgical instrument such as retractors, electrosurgical cutters, electrosurgical coagulators, forceps, needle holders, scissors, blades and irrigators.
U.S. Pat. No. 5,339,799 to Kami et al., which is incorporated herein by reference, describes a medical system comprising a medical apparatus including an operation unit manipulated by a surgeon and a treatment section formed away from the operation unit for treating a subject, a detector or a pressure sensor for detecting a state of contact between the subject and the treatment section, and a reproduction mechanism for amplifying a small contact pressure according to the output of the detector and thus reproducing the state of contact so that the surgeon can perceive the state of contact.
US Patent Application Publication 2002/0128636 to Chin et al., which is incorporated herein by reference, describes techniques for positioning a medical instrument at a desired biological target tissue site. The system includes an elongated sheath having a deflectable distal end configured to deflect or otherwise position at least a portion of a medical instrument during a surgical procedure, allowing for the placement of the deflected portion adjacent or proximate to a predetermined target tissue surface. The positioning system may be incorporated into the medical instrument. The medical instrument may be an ablation system. The medical instrument may be controlled by a robot during a robotic minimally invasive surgical procedure. The robot can telescopically translate or rotate the medical instrument in order to position the ablation sheath and the ablation element correctly to produce the ablation of tissue.
U.S. Pat. No. 5,078,140 to Kwoh, which is incorporated herein by reference, describes a method for computer-controlled stereotactic surgery. The method utilizes an imaging device, a robotic arm, and a means for controlling the robotic arm. The imaging device provides information regarding the structure of the bodily location to be operated on. The robotic arm is utilized to precisely orient the surgical tools or other implements used in conducting the surgery or related procedure. The control means, such as a computer, utilizes information received from the imaging device, alone or together with other information, to control the robotic arm.
U.S. Pat. No. 6,490,467 to Bucholz et al., which is incorporated herein by reference, describes a system for use during a medical or surgical procedure on a body. The system generates an image representing the position of one or more body elements during the procedure using scans generated by a scanner prior to or during the procedure. The image data set has reference points for each of the body elements, the reference points of a particular body element having a fixed spatial relation to the particular body element. The system includes an apparatus for identifying, during the procedure, the relative position of each of the reference points of each of the body elements to be displayed.
US Patent Application Publication 2002/0087151 to Mody et al., which is incorporated herein by reference, describes techniques for ablating a selected portion of a contact surface of biological tissue. The system includes an elongated ablation sheath having a preformed shape adapted to substantially conform a predetermined surface thereof with the contact surface of the tissue. The ablation sheath defines an ablation lumen sized to slidably receive an elongated ablative device longitudinally therethrough. The ablative device includes a flexible ablation element selectively generating an ablative field sufficiently strong to cause tissue ablation. Advancement of the ablation element slidably through the ablation lumen of the ablation sheath selectively places the ablation element along the ablation path for guided ablation on the contact surface when the predetermined surface is in suitable contact therewith. The ablation sheath or ablation element can be controlled by a robot during a robotic minimally-invasive surgical procedure. The robot can telescopically translate or rotate the ablation sheath or ablation element in order to position the ablation sheath and the ablation element correctly to produce the ablation of tissue.
U.S. Pat. No. 6,400,980 to Lemelson, which is incorporated herein by reference, describes a computerized imaging system that is employed to sense the position of an endoscopic treatment system within the body of a patient. In a preferred embodiment, the system provides real-time computer control to maintain and adjust the position of the treatment system and/or the position of the patient relative to the treatment system; and also optionally provides real-time computer control of the operation of the treatment system itself. Other embodiments include a steerable catheter system having a rotatable abrasive member actuated by an external magnetic field.
U.S. Pat. No. 5,681,260 to Ueda et al., which is incorporated herein by reference, describes guiding apparatus for guiding an insertable body within an inspected object. The guiding apparatus comprises a guided part and a guiding device provided outside the inspected object, adapted to magnetically guide the guided part. The guiding device includes a driving device for moving the guiding part at least two-dimensionally.
U.S. Pat. Nos. 6,507,751, 6,014,580, 6,212,419, and 6,157,853 to Blume et al., which are incorporated herein by reference, describe methods, including interactive displays, of modifying magnetic fields to move or guide surgically implanted objects which comprise magnetic material.
U.S. Pat. No. 6,475,223 to Werp et al., which is incorporated herein by reference, describes a method for moving an implant in the body by applying mechanical pushing forces and magnetically steering the implant on a predetermined path by means of making changes in an externally applied magnetic system.
U.S. Pat. No. 5,125,888 to Howard et al., which is incorporated herein by reference, describes a method of observing the location and movement of a magnetic object within the body, employing magnetic systems.
U.S. Pat. No. 4,173,228 to Van Steenwyk et al.; U.S. Pat. Nos. 5,558,091, 5,729,129, and 5,752,513 to Acker et al.; and U.S. Pat. No. 5,833,608 to Acker, all of which are incorporated herein by reference, describe methods and apparatus for magnetic determination of position and orientation.
U.S. Pat. Nos. 5,546,951 and 6,066,094 to Ben-Haim, and European Patent 0 776 176 to Ben-Haim et al., which are assigned to the assignee of the present patent application and are incorporated herein by reference, describe methods for sensing an electrical property of heart tissue, for example, local activation time, as a function of the precise location within the heart. The data are acquired with a catheter that has electrical and location sensors in its distal tip, and which is advanced into the heart. Techniques for sensing cardiac electrical activity are also described in U.S. Pat. No. 5,471,982 to Edwards et al., commonly-assigned U.S. Pat. Nos. 5,391,199 and 6,066,094 to Ben-Haim, U.S. Pat. No. 6,052,618 to Dahlke et al., and in PCT Patent Publications WO 94/06349 and WO 97/24981, which are incorporated herein by reference.
Methods of creating a map of the electrical activity of the heart based on these data are disclosed in U.S. Pat. Nos. 6,226,542 and 6,301,496 to Reisfeld, which are assigned to the assignee of the present patent application and are incorporated herein by reference. As indicated in these patents, location and electrical activity is typically initially measured on about 10 to about 20 points on the interior surface of the heart. These data points are then generally sufficient to generate a preliminary reconstruction or map of the cardiac surface to a satisfactory quality. The preliminary map is often combined with data taken at additional points in order to generate a more comprehensive map of the heart's electrical activity. In clinical settings, it is not uncommon to accumulate data at 100 or more sites to generate a detailed, comprehensive map of heart chamber electrical activity. The generated detailed map may then serve as the basis for deciding on a therapeutic course of action, for example, tissue ablation, which alters the propagation of the heart's electrical activity and restores normal heart rhythm. Methods for constructing a cardiac map of the heart are also disclosed in U.S. Pat. Nos. 5,391,199 and 6,285,898 to Ben-Haim, and in U.S. Pat. Nos. 6,368,285 and 6,385,476 to Osadchy et al., which are assigned to the assignee of the present patent application and are incorporated herein by reference.
European Patent Application EP 1 125 549 and corresponding U.S. patent application Ser. No. 09/506,766 to Ben-Haim et al., which are assigned to the assignee of the present patent application and are incorporated herein by reference, describe techniques for rapidly generating an electrical map of a chamber of the heart. The catheter used for these techniques comprises a contact electrode at the distal tip of the catheter and an array of non-contact electrodes on the shaft of the catheter near the distal end. The catheter also comprises at least one position sensor. Information from the non-contact electrodes and contact electrode is used for generating a geometric and electrical map of the cardiac chamber.